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目的研究与修订连蒲双清片的质量标准。方法采用TLC方法对连蒲双清片中的盐酸小檗碱、蒲公英进行定性鉴别;应用HPLC法选用十八烷基硅烷键合硅胶柱C18,以磷酸盐缓冲液-乙腈(60:40)为流动相,检测波长263nm,流速1.0ml/min,柱温25℃对连蒲双清片中的盐酸小檗碱进行含量测定。结果盐酸小檗碱、蒲公英的TLC鉴别方法专属性强,简单可行。以上述HPLC法测定,盐酸小檗碱的浓度在4～60μg/ml范围内,线性关系良好(R=0.9999,N=6);盐酸小檗碱的回收率为100.41%,RSD=0.12%具有较好。结论本方法可对连蒲双清片的主要药味准确地进行定性或定量测定,有效地控制连蒲双清片的质量。
Objective To study and revise the quality standards of Lian Po Shuangqing. Methods The berberine hydrochloride and dandelion in Lianpu Shuangqing tablets were qualitatively identified by TLC method; the octadecylsilane bonded silica gel column C18 was selected by HPLC and the phosphate buffer-acetonitrile (60:40) was used as the mobile phase. The detection wavelength was 263 nm, the flow rate was 1.0 ml/min, and the column temperature of 25°C was used to determine the content of berberine hydrochloride in Lianpu Shuangqing tablets. RESULTS TLC identification methods for berberine hydrochloride and dandelion were specific, simple and feasible. According to the above HPLC method, the concentration of berberine hydrochloride was in the range of 4 to 60 μg/ml, and the linear relationship was good (R=0.9999, N=6); the recovery rate of berberine hydrochloride was 100.41%, and RSD=0.12% had better. Conclusion This method can accurately and quantitatively determine the main odor of Lianpu Shuangqing Tablets and effectively control the quality of Lianpu Shuangqing Tablets.